FDA Issues Guidance on ANDA Submission Process for Synthetic Peptide Drugs

The FDA clarified in a new guidance released yesterday when it is appropriate for drug sponsors to submit an abbreviated new drug application (ANDA) for a synthetic peptide drug product that references an already-approved synthetic peptide of recombinant DNA origin.

Advances in technology, such as high-resolution mass spectrometry and liquid chromatography, now make it possible for sponsors to characterize peptide products for ANDA submissions and to show the sameness of the active ingredient, the agency said, adding that an ANDA would be appropriate if the applicant can demonstrate that the level of any impurity in the generic is the same or lower than of that found in the reference-listed drug.

A generic synthetic peptide must not contain a new peptide-related impurity that is more than 0.5 percent of the drug substance. And the sponsor must also characterize each new specified peptide-related impurity and provide a justification for why each new impurity would not affect the generic drug’s safety or effectiveness, the agency said.